Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2018 Mar 8;13(3):e0193569.
doi: 10.1371/journal.pone.0193569. eCollection 2018.

A randomized controlled trial-based algorithm for insulin-pump therapy in hyperglycemic patients early after kidney transplantation

Johannes M Werzowa  1   2 , Marcus D Säemann  3   4 , Alexander Mohl  1 , Michael Bergmann  1 , Christopher C Kaltenecker  1 , Wolfgang Brozek  2 , Andreas Thomas  5 , Michael Haidinger  1 , Marlies Antlanger  1 , Johannes J Kovarik  1 , Chantal Kopecky  1 , Peter X K Song  6 , Klemens Budde  7 , Julio Pascual  8 , Manfred Hecking  1
Affiliations
Randomized Controlled Trial

A randomized controlled trial-based algorithm for insulin-pump therapy in hyperglycemic patients early after kidney transplantation

Johannes M Werzowa et al. PLoS One. .

Abstract

Treating hyperglycemia in previously non-diabetic individuals with exogenous insulin immediately after kidney transplantation reduced the odds of developing Posttransplantation Diabetes Mellitus (PTDM) in our previous proof-of-concept clinical trial. We hypothesized that insulin-pump therapy with maximal insulin dosage during the afternoon would improve glycemic control compared to basal insulin and standard-of-care. In a multi-center, randomized, controlled trial testing insulin isophane for PTDM prevention, we added a third study arm applying continuous subcutaneous insulin lispro infusion (CSII) treatment. CSII was initiated in 24 patients aged 55±12 years, without diabetes history, receiving tacrolimus. The mean daily insulin lispro dose was 9.2±5.2 IU. 2.3±1.1% of the total insulin dose were administered between 00:00 and 6:00, 19.5±11.6% between 6:00 and 12:00, 62.3±15.6% between 12:00 and 18:00 and 15.9±9.1% between 18:00 and 24:00. Additional bolus injections were necessary in five patients. Mild hypoglycemia (52-60 mg/dL) occurred in two patients. During the first post-operative week glucose control in CSII patients was overall superior compared to standard-of-care as well as once-daily insulin isophane for fasting and post-supper glucose. We present an algorithm for CSII treatment in kidney transplant recipients, demonstrating similar safety and superior short-term efficacy compared to standard-of-care and once-daily insulin isophane.

PubMed Disclaimer

Conflict of interest statement

Competing Interests: A.T. is an employee of Medtronic Inc. This does not alter our adherence to PLOS One policies on sharing data and materials. M.S. received an unrestricted grant from Astellas Pharma Europe. This does not alter our adherence to PLOS One policies on sharing data and materials. Lilly Inc. Austria has provided study medication (insulin), and Medtronic Inc. Austria has provided insulin pumps including consumables for this study. This does not alter our adherence to PLOS One policies on sharing data and materials. The other authors declare that no conflict of interest exists.

Figures

Fig 1
Fig 1. Enrollment and randomization of the SAPT-NODAT and ITP-NODAT trial participants at the Medical University of Vienna.
Fig 2
Fig 2. Insulin infusion rates.
Mean CSII basal rate ± standard deviation after dose titration over 24 hours.
Fig 3
Fig 3. Mean BG profiles of patients under CSII treatment, basal insulin isophane, and standard-of-care over 7 days after transplantation.
CSII patients had significantly lower BG compared to the control group for all times of the day except for pre-lunch and compared to the basal insulin group for fasting and post-supper glucose (2-way ANOVA, Bonferroni post-hoc test): (A) fasting, p<0.0001 vs. control and vs. basal insulin; 5% (CSII group) 8% (basal insulin group) and 34% (control group) of BG results were missing. (B) pre-lunch; 25% (CSII group) 14% (basal insulin group) and 49% (control group) of BG results were missing. (C) pre-supper, p = 0.009 vs. control; 10% (CSII group) 9% (basal insulin group) and 49% (control group) of BG results were missing. (D) post-supper, p<0.0001 vs. control and p = 0.004 vs. basal insulin; 12% (CSII group) 24% (basal insulin group) and 68% (control group) of BG results were missing.
See this image and copyright information in PMC

References

    1. USRDS. US Renal Data System, Annual Report 2011. http://www.usrds.org/2011/view/v2_07.asp 2011.
    1. Chakkera HA, Weil EJ, Castro J, Heilman RL, Reddy KS, Mazur MJ, et al. Hyperglycemia during the immediate period after kidney transplantation. Clin J Am Soc Nephrol. 2009;4(4):853–9. Epub 2009/04/03. doi: CJN.05471008 [pii] doi: 10.2215/CJN.05471008 . - DOI - PMC - PubMed
    1. Hecking M, Werzowa J, Haidinger M, Horl WH, Pascual J, Budde K, et al. Novel views on new-onset diabetes after transplantation: development, prevention and treatment. Nephrol Dial Transplant. 2013;28(3):550–66. Epub 2013/01/19. doi: 10.1093/ndt/gfs583 . - DOI - PMC - PubMed
    1. Chakkera HA, Knowler WC, Devarapalli Y, Weil EJ, Heilman RL, Dueck A, et al. Relationship between inpatient hyperglycemia and insulin treatment after kidney transplantation and future new onset diabetes mellitus. Clin J Am Soc Nephrol. 2010;5(9):1669–75. Epub 2010/06/19. doi: 10.2215/CJN.09481209 ; PubMed Central PMCID: PMC2974410. - DOI - PMC - PubMed
    1. Hecking M, Haidinger M, Doller D, Werzowa J, Tura A, Zhang J, et al. Early Basal insulin therapy decreases new-onset diabetes after renal transplantation. J Am Soc Nephrol. 2012;23(4):739–49. Epub 2012/02/22. doi: ASN.2011080835 [pii] doi: 10.1681/ASN.2011080835 . - DOI - PMC - PubMed

Publication types